Ultrasound Elastography of Breast Lesions

Breast Neoplasms Clinical Trial

— BE1  

Official title:

Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716482
• Other study ID #: A00152-53
• Status: Completed
• Phase: N/A
• First received: July 14, 2008
• Last updated: September 2, 2013
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2013
• Source: SuperSonic Imagine
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthUnited Kingdom: National Health ServiceUnited States: Institutional Review BoardGermany: German Institute of Medical Documentation and Information
• Study type: Observational

Clinical Trial Summary

Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1681
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• patients who have been referred to a breast ultrasound because of a positive physical palpation and/or positive mammograms and/or positive ultrasound and/or positive MRI.

• female

• age 21 or older

• provide informed consent

Exclusion Criteria:

• Women who are unwilling or unable to provide informed consent

• Women with breast implants

• Women with superficial lesions or lesions on skin (with the most superficial surface of the lesion within 5 mm of the skin surface)

• Women who are pregnant or breastfeeding

• Women who are undergoing chemotherapy or radiotherapy for any cancer

• Women with previous breast conserving surgery on the breast of interest Note:

Previous excision of a benign lesion 4 cm or more away from the suspected lesion does not constitute an exclusion criterion.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
France	Hôpital Privé Jean Mermoz	Lyon
France	University Hospital La Timone	Marseille
France	Centre Antoine Lacassagne	Nice
France	Institut Curie	Paris
Germany	University Hospital, Frauenklinik	Greifswald
Germany	University Hospital Schleswig-Holstein	Kiel
Germany	Marienhospital, Klinik für Radiologie	Osnabrück
Germany	German Diagnostic Clinic	Wiesbaden
Italy	Ospedale Civile di Gorizia	Gorizia
United Kingdom	Charings Cross Hospital	London
United States	Boston Medical Center, Radiology	Boston	Massachusetts
United States	Northwestern Memorial Hospital, Dept. of Radiology	Chicago	Illinois
United States	Sally Jobe Breast Center	Denver	Colorado
United States	University of Southern California - LAC+USC Medical Center, OPD Rm 3P61	Los Angeles	California
United States	Yale Medical Center, Department of Diagnostic Radiology	New Haven	Connecticut
United States	Thomas Jefferson Medical Center, Department of Radiology	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
SuperSonic Imagine

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  United Kingdom, 

References & Publications (2)

Berg WA, Cosgrove DO, Doré CJ, Schäfer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastograph — View Citation

Cosgrove DO, Berg WA, Doré CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics	Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size.; Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions.; Based on 939 lesions.	2 years	No
Secondary	Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature	614 benign and 144 malignant breast lesions were scanned in SWE 3 consecutive times, and the similarity of the 3 images was evaluated by the investigator.	performed on the same day, within 2 years from study start date	No
Secondary	Intraobserver Reliability of Quantitative SWE Measurements	614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.	performed on the same day, within 2 years from study start date	No
Secondary	Interobserver Agreement of B Mode Ultrasound and SWE Features	614 benign and 144 malignant breast masses.	performed on the same day, after study completion	No